AGILIS NXT STEERABLE INTRODUCER

K083083 · St Jude Medical · DYB · Nov 6, 2008 · Cardiovascular

Device Facts

• Record ID: K083083
• Device Name: AGILIS NXT STEERABLE INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.

Device Story

The Agilis™ NxT Steerable Introducer is a catheter introducer system comprising a dilator, guidewire, and steerable sheath. It is used in clinical settings to facilitate flexible positioning of cardiovascular catheters within the heart. The device features a handle with a rotating collar that allows the operator to deflect the sheath tip clockwise (≥ 180°) and counter-clockwise (≥ 90°). It includes a hemostasis valve to reduce blood loss, a sideport with a three-way stopcock for fluid infusion, blood sampling, pressure monitoring, or aspiration, and distal vent holes to minimize cavitation. A radiopaque tip marker is included to assist with fluoroscopic visualization during placement. The device is operated by a physician to provide a stable, steerable pathway for secondary cardiovascular catheters.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Catheter introducer system consisting of a dilator, guidewire, and steerable sheath. Features include a hemostasis valve, sideport with three-way stopcock, and radiopaque tip marker. Mechanical deflection mechanism controlled via handle-mounted rotating collar. No software or electronic components.

Indications for Use

Indicated for patients requiring the introduction of cardiovascular catheters into the heart.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• St. Jude Medical Agilis™ NxT Steerable Introducer, Catheter Introducer (K061363)

Submission Summary (Full Text)

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K083083

## 510(k) Summary As required by 21 CFR 807.92(c)

s required by 21 CFR 807.92(c)

# NOV - 6 2008

## 510(k) Number:

Date Prepared:

October 3, 2008

Submitter Information:

Submitter's Name/ Address:

St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126

Contact Person:

Laura Moen-Ftacek Regulatory Affairs Specialist Tel: [phone] Fax: [phone] [e-mail]

#### Device Information:

Trade Name: Common Name: Classification Name: Class:

Agilis™ NxT Steerable Introducer Catheter Introducer Introducer, Catheter Class II, 21 CFR 870.1340, Product Code DYB

## Predicate Device:

St. Jude Medical Agilis™ NxT Steerable Introducer, Catheter Introducer (K061363)

#### Device Description:

The St. Jude Medical Agilis™ NxT Stecrable Introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer if fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counter-clockwise ≥ 90°15 The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

#### Indications for Use:

The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.

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#### Comparison to Predicate Devices:

The Agilis™ NxT Steerable Introducer (40cm) has an Indication for Use statement that is included in the broader Indications for Use statement of the predicate Agilis™ NxT Steerable Introducer. The Agilis™ NxT Steerable Introducer (40cm) utilizes many of the same materials and design principles and the fumdamental scientific technology of the device remain unchanged,

## Summary of Non-Clinical Testing:

Bench testing of the Agilis™ NxT Stecrable Introducer was performed to support substantial equivalence. Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer meets product specifications and performance requirements.

#### Statement of Equivalence:

The Agilis™ NxT Steerable Introducer has similar indications for use and technological characteristics as the predicate device. Based on this and the design and engineering data provided in the pre-market notification, SJM's Agilis™ NxT Steerable Introducer has been shown to be substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2008

St. Jude Medical c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K083083

> Agilis NXT Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: October 15, 2008 Received: October 16, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. T o general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA moy publish further announcements concerning your device in the Federal Register.

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Page 2 Mr. Mark Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Dma R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(K) Number (if known):

Device Name: AgilisTM NxT Steerable Introducer

Indications for Use:

The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

oning & la misses

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Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_KO8308 3